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Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

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ClinicalTrials.gov Identifier: NCT00656084
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
US Oncology Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Interventions Drug: gemcitabine
Drug: mitoxantrone
Drug: rituximab
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemzar + Novantrone + Rituxan
Hide Arm/Group Description Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
Period Title: Overall Study
Started 16
Completed 9
Not Completed 7
Reason Not Completed
Adverse Event             4
Withdrawal by Subject             1
Patient Request             1
Investigator Request             1
Arm/Group Title Gemzar + Novantrone + Rituxan
Hide Arm/Group Description Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
68  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
5
  31.3%
Male
11
  68.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 16 participants
16
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Objective Response Rate (CR + PR)
Hide Description Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population
Arm/Group Title Gemzar + Novantrone + Rituxan
Hide Arm/Group Description:
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.7
(21.3 to 73.4)
2.Secondary Outcome
Title Duration of Response
Hide Description

The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Time Frame From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.
Hide Outcome Measure Data
Hide Analysis Population Description
For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.
Arm/Group Title Gemzar + Novantrone + Rituxan
Hide Arm/Group Description:
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: months
7.9
(4.8 to 31.3)
3.Secondary Outcome
Title Overall Survival (OS) Rate at 1 Year
Hide Description OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time Frame 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Gemzar + Novantrone + Rituxan
Hide Arm/Group Description:
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of Survival
0.57
(0.28 to 0.78)
4.Secondary Outcome
Title Progression-free Survival Rate at 1 Year.
Hide Description PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Time Frame 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Gemzar + Novantrone + Rituxan
Hide Arm/Group Description:
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of Progression-free Survival
0.54
(0.24 to 0.77)
Time Frame During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description For treated patients only, assessed at each treatment visit.
 
Arm/Group Title Gemzar + Novantrone + Rituxan
Hide Arm/Group Description Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
All-Cause Mortality
Gemzar + Novantrone + Rituxan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemzar + Novantrone + Rituxan
Affected / at Risk (%) # Events
Total   4/15 (26.67%)    
Gastrointestinal disorders   
PAIN ABDO  1  1/15 (6.67%)  1
General disorders   
CACHEXIA  1  1/15 (6.67%)  1
FEVER  1  2/15 (13.33%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemzar + Novantrone + Rituxan
Affected / at Risk (%) # Events
Total   15/15 (100.00%)    
Blood and lymphatic system disorders   
ANEMIA  1  13/15 (86.67%)  49
EDEMA PERIPH  1  1/15 (6.67%)  4
FEBRILE NEUTROPENIA  1  1/15 (6.67%)  1
LEUKOPENIA  1  9/15 (60.00%)  50
NEUTROPENIA  1  15/15 (100.00%)  64
THROMBOCYTHEM  1  1/15 (6.67%)  3
THROMBOCYTOPENIA  1  12/15 (80.00%)  63
Gastrointestinal disorders   
ABDO ENLARGE  1  1/15 (6.67%)  1
ANOREXIA  1  7/15 (46.67%)  10
CONSTIP  1  6/15 (40.00%)  7
DEHYDRAT  1  1/15 (6.67%)  1
DIARRHEA  1  2/15 (13.33%)  3
DRY MOUTH  1  3/15 (20.00%)  3
FLATUL  1  1/15 (6.67%)  1
NAUSEA  1  9/15 (60.00%)  15
PAIN ABDO  1  2/15 (13.33%)  2
RECTAL DIS  1  1/15 (6.67%)  1
TASTE PERVERS  1  3/15 (20.00%)  3
VOMIT  1  2/15 (13.33%)  3
General disorders   
ASTHENIA  1  14/15 (93.33%)  35
CHILLS  1  2/15 (13.33%)  4
DEPRESSION  1  1/15 (6.67%)  1
FEVER  1  3/15 (20.00%)  3
HEADACHE  1  1/15 (6.67%)  2
INSOMNIA  1  1/15 (6.67%)  1
PAIN  1  3/15 (20.00%)  3
SWEAT  1  2/15 (13.33%)  4
WEIGHT DEC  1  2/15 (13.33%)  2
Immune system disorders   
ALLERG REACT  1  2/15 (13.33%)  3
Infections and infestations   
CELLULITIS  1  1/15 (6.67%)  1
INFECT  1  2/15 (13.33%)  2
Investigations   
PAIN CHEST SUBSTERN  1  1/15 (6.67%)  1
PALLOR  1  1/15 (6.67%)  2
PLAT ABNORM  1  1/15 (6.67%)  1
VASODILAT  1  1/15 (6.67%)  1
Metabolism and nutrition disorders   
BILIRUBINEM  1  1/15 (6.67%)  1
BUN INC  1  1/15 (6.67%)  1
CREATININE INC  1  1/15 (6.67%)  1
HYPERGLYCEM  1  2/15 (13.33%)  4
HYPERURICEM  1  1/15 (6.67%)  1
HYPOCALCEM  1  2/15 (13.33%)  3
HYPONATREM  1  1/15 (6.67%)  1
HYPOPROTEINEM  1  2/15 (13.33%)  4
HYPOVOLEM  1  1/15 (6.67%)  1
LAB TEST ABNORM  1  1/15 (6.67%)  2
LDH INC  1  2/15 (13.33%)  2
PHOSPHATASE ALK INC  1  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  1/15 (6.67%)  1
BACK PAIN  1  1/15 (6.67%)  1
MYALGIA  1  2/15 (13.33%)  2
PAIN BONE  1  1/15 (6.67%)  3
Nervous system disorders   
DIZZINESS  1  3/15 (20.00%)  3
Renal and urinary disorders   
HEMATURIA  1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
COUGH INC  1  1/15 (6.67%)  1
DYSPNEA  1  3/15 (20.00%)  5
FLU SYND  1  1/15 (6.67%)  1
RHINITIS  1  1/15 (6.67%)  1
STOMATITIS  1  1/15 (6.67%)  2
Skin and subcutaneous tissue disorders   
ALOPECIA  1  3/15 (20.00%)  3
MUCOUS MEM DIS  1  1/15 (6.67%)  1
PRURITUS  1  2/15 (13.33%)  2
RASH  1  3/15 (20.00%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lawrence E. Garbo
Organization: New York Oncology Hematology
Phone: (518) 489-0044
Responsible Party: Dr. Lawrence Garbo, Principal Investigator, US Oncology Research
ClinicalTrials.gov Identifier: NCT00656084     History of Changes
Other Study ID Numbers: 04-026
First Submitted: April 4, 2008
First Posted: April 10, 2008
Results First Submitted: February 2, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016